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Our Research Ethics Program is responsible for the ethical and regulatory compliance of research that involves human subjects. We are committed to protecting the rights and welfare of subjects enrolled in its research activities.
As a result, in 2009 the PSI Board of Directors established a Research Ethics Board (REB) to review all human subjects research conducted by us or under our direction.
PSI maintains a Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), and our REB is registered with OHRP.
Our REB accepts complete submissions on a rolling basis. A submission determined to be minimal risk will be reviewed immediately. Those determined to be more than minimal risk will be reviewed by the full board.
Since the overwhelming majority of the submissions to the REB meet the regulatory criteria for expedited approval, our REB convenes on an as-needed basis. If a submission is found to require a full board review, the REB Manager will convene the board within four weeks of submission.
Is my activity research? Does my activity require ethical review? We is involved in activity X, but we’re not recruiting participants, do we need ethical review?
These are common questions posed by our staff and researchers. Our Research Ethics Program has developed the following guidance to help staff determine when activities are required to receive ethical review and guidance on questions to consider at this stage of the process.
Understanding our REB review process and elements of a complete submission are key to an efficient and quality review. Our Research Ethics Program developed the following documents to provide detailed explanation on the review process, training requirements for key personnel and how to prepare a complete packet for our REB.
The REB requires the completion of the appropriate forms for new submissions, modification requests and continuing review applications.